Continuing cetuximab in combination with chemotherapy after first progression may be efficacious in selected patients with metastatic colorectal cancer (mCRC), a study published in the journal Annals of Oncology has shown.1
Cetuximab plus chemotherapy is a first-line treatment modality in patients with metastatic KRAS and NRAS wild type CRC; however, there are currently no data on the effect of continuing anti-epidermal growth factor receptor (EGFR) therapy beyond progression.
For the multicenter, open-label, phase 2 trial, researchers in Italy sought to evaluate the efficacy of cetuximab plus 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) as second-line treatment for patients with KRAS exon 2 wild type mCRC who were treated with first-line 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus cetuximab.
Researchers enrolled 153 patients and randomly assigned 75 to receive FOLFOX plus cetuximab and 79 to FOLFOX alone.
Results showed that median progression-free survival was 6.4 months (95% CI, 4.7 – 8.0) with cetuximab compared with 4.5 months (95% CI, 3.3 – 5.7) with FOLFOX alone (HR, 0.81; 95% CI, 0.58 – 1.12; P = .19).
Researchers found that progression-free survival was longer in the FOLFOX plus cetuximab arm among patients with KRAS, NRAS, BRAF, and PIK3CA wild type tumors. Median progression-free survival was 6.9 months (95% CI, 5.5 – 8.2) with FOLFOX plus cetuximab vs 5.3 months (95% CI, 3.7 – 6.9) with FOLFOX (HR, 0.56; 95% CI, 0.33 – 0.94; P = .025). Researchers also observed a trend in prolonged overall survival with immunotherapy (HR, 0.57; 95% CI, 0.32 – 1.02; P = .056).
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The findings suggest that continuing cetuximab and chemotherapy in molecularly selected patients following first progression should be confirmed in phase 3 studies.
- Ciardiello F, Normanno N, Martinelli E, et al. Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase 2 trial of FOLFOX plus cetuximab versus FOLFOX [published online ahead of print March 21, 2016]. Ann Oncol. doi: 10.1093/annonc/mdw136.